Central Venous CathetersNCT03996733
Using A Gelatin-Based Model In USG-Guided Jugular Venous Catheter Placement Training
A study testing Lecture, Demo Video and UltrasoundImaging in people with Central Venous Catheters and Vascular Access Devices, run by Zeki Tuncel Tekgul at 1 site in Turkey (Türkiye).
Trial summary
An education model with a homemade jugular venous catheterization model will be compared to the conventional training model for ultrasound-guided central jugular line catheterization. The study will include 60 residents to be divided into two groups with stratified random sampling. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheters, Vascular Access Devices, Education
- What is being tested?
- Lecture, Demo Video and UltrasoundImaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents
Who cannot join
- Any experience on jugular venous catheterization
- Experience of ultrasound guided interventions of any kind.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Karabağlar, İzmir, 35170
About this study
Official title: The Effectiveness Of Using A Gelatin-Based Model In Ultrasonography Guided Jugular Central Venous Catheter Placement Training
An education model with a homemade jugular venous catheterization model will be compared to the conventional training model for ultrasound-guided central jugular line catheterization.
The study will include 60 residents to be divided into two groups with stratified random sampling.
Read more
Training session for the control group (Group 2) will include a lecture about the subject, a demo video presentation, and practice of visualization of right jugular vein on a real human subject.
Training session for the model group (Group 1) will include the same as GControl with the addition of the puncture practice on the homemade jugular venous catheterization model(HJVCM) with ultrasound guidance.
Both groups will be tested with another HJVCM individually and the results of the success and fail parameters will be compared.
Read the detailed description
According to the latest guidelines, ultrasound guidance has become the golden standard in Jugular Central Venous Catheter applications. This reveals the necessity of theoretical and practical training on USG for jugular central venous catheter training. Models for jugular venous catheterization training are few in number and also expensive. Thus, the investigators built an Homemade Jugular Venous Catheterization Model which meant to be cheap and easy to make and transport. With this study, the investigators will test whether this model will provide any benefit to the success of the training on USG Guided Jugular Venous Catheterization.
Two different training sessions are planned as one will include the training model and the other will not. The study will be conducted with resident physicians without any experience on jugular venous catheterization or ultrasound-guided interventions of any kind. Participants will be divided into two groups with stratified random sampling (According to specialties and years of residency) and the both will attend to a 30 minutes lecture on jugular venous catheterization with US guidance and basic ultrasound principles including a demo video illustrating the procedure. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. The model training group will be named Group 1 and control group will be named Group 2. Group 1 will also practice jugular vein puncture on the training model. After training sessions, each participant will be tested with a different model placed in a manikin. The assessment session will include successful visualization of the jugular vein, puncture of the jugular vein, and insertion of the guide wire. Evaluation of the success and fail parameters (explained in outcome parameters) will be monitored by four educated supervisors. The sessions for both of the groups are planned to take 120 minutes in total and the assessment will be limited to five minutes individually.
- Conditions
- Central Venous Catheters, Vascular Access Devices, Education, Simulation Training, Ultrasonography, Interventional
- Being tested
- Lecture, Demo Video, UltrasoundImaging, ModelTraining
- Keywords
- Training, Education, Homemade, Model, Central Venous Catheterization, Ultrasound Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LectureOther
Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.
Demo VideoOther
Investigators of the study prepared a detailed demo-video showing insertion of a jugular central venous catheter with USG guidance. Principal investigator will vocalize the video in real-time.
UltrasoundImagingOther
Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.
ModelTrainingOther
Participants will exercise the proper punction of juguler vein with USG guidance on the homemade jugular venous catheterization training model.
Training model will include carotid artery, trachea and plaure in accordance with the real anatomy.
| Study group | Role | What they receive |
|---|---|---|
| GControl | Active comparator | Participants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject. Receives: Other: Lecture; Other: Demo Video; Other: UltrasoundImaging |
| GModel | Experimental | Participants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject.
Participants in this group will also practice jugular vein puncture on our homemade jugular central venous catheterization training model. Receives: Other: Lecture; Other: Demo Video; Other: UltrasoundImaging; Other: ModelTraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Of The Catheterization
Successful visualization of the jugular vein in long axis, successful puncture and draining the fluid in the jugular vein, successful visualization of insertion of the guide wire. All required.
Measured: 5 minutes
Secondary outcomes (6)
Successful Visualization
Successful visualization of the jugular vein in long axis. Yes or No.
Measured: 5 minutes
Time Of The Successful Visualization
Total time from puncture of the model's skin to the successful visualization of the jufular vein in long axis.
Measured: 5 minutes
Puncture Count
Total count of punctures on model skin.
Measured: 5 minutes
Number Of Changes Of Needle Angle During The Procedure
Retraction and orientation of the needle at different angles before the puncture of the jugular vein.
Measured: 5 minutes
Puncture Time
Total time from puncture of the model's skin to the successful puncture of the jugular vein.
Measured: 5 minutes
Fail Of The Procedure
Any of these four endpoints;
- Puncture of pleura
- Puncture of carotid artery
- Puncture of the base(Too deep needle advancement)
- Exceeding five minutes, before successful jugular venous catheterization
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jul 2019
- Primary completion30 Jul 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeki Tuncel Tekgul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeki Tuncel Tekgul, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996733
- Sponsor's protocol ID
- JugulerUsgMaket
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2019
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Using A Gelatin-Based Model In Ultrasonography Guided Jugular Central Venous Catheter Placement Training
- ClinicalTrials.gov ID
- NCT03996733
- Acronym / sponsor ID
- JugulerUsgMaket
- Conditions
- Central Venous Catheters, Vascular Access Devices, Education, Simulation Training, Ultrasonography, Interventional
- Keywords
- Training, Education, Homemade, Model, Central Venous Catheterization, Ultrasound Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Zeki Tuncel TekgulUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An education model with a homemade jugular venous catheterization model will be compared to the conventional training model for ultrasound-guided central jugular line catheterization.
The study will include 60 residents to be divided into two groups with stratified random sampling.
Training session for the control group (Group 2) will include a lecture about the subject, a demo video presentation, and practice of visualization of right jugular vein on a real human subject.
Training session for the model group (Group 1) will include the same as GControl with the addition of the puncture practice on the homemade jugular venous catheterization model(HJVCM) with ultrasound guidance.
Both groups will be tested with another HJVCM individually and the results of the success and fail parameters will be compared.
Detailed description
According to the latest guidelines, ultrasound guidance has become the golden standard in Jugular Central Venous Catheter applications. This reveals the necessity of theoretical and practical training on USG for jugular central venous catheter training. Models for jugular venous catheterization training are few in number and also expensive. Thus, the investigators built an Homemade Jugular Venous Catheterization Model which meant to be cheap and easy to make and transport. With this study, the investigators will test whether this model will provide any benefit to the success of the training on USG Guided Jugular Venous Catheterization.
Two different training sessions are planned as one will include the training model and the other will not. The study will be conducted with resident physicians without any experience on jugular venous catheterization or ultrasound-guided interventions of any kind. Participants will be divided into two groups with stratified random sampling (According to specialties and years of residency) and the both will attend to a 30 minutes lecture on jugular venous catheterization with US guidance and basic ultrasound principles including a demo video illustrating the procedure. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. The model training group will be named Group 1 and control group will be named Group 2. Group 1 will also practice jugular vein puncture on the training model. After training sessions, each participant will be tested with a different model placed in a manikin. The assessment session will include successful visualization of the jugular vein, puncture of the jugular vein, and insertion of the guide wire. Evaluation of the success and fail parameters (explained in outcome parameters) will be monitored by four educated supervisors. The sessions for both of the groups are planned to take 120 minutes in total and the assessment will be limited to five minutes individually.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GControl | Active comparator | Other: Lecture, Other: Demo Video, Other: UltrasoundImagingParticipants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject. |
| GModel | Experimental | Other: Lecture, Other: Demo Video, Other: UltrasoundImaging, Other: ModelTrainingParticipants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject. Participants in this group will also practice jugular vein puncture on our homemade jugular central venous catheterization training model. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents
Key exclusion criteria (2 listed)
- Any experience on jugular venous catheterization
- Experience of ultrasound guided interventions of any kind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LecturePrincipal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines. | Other | GControl, GModel |
| Demo VideoInvestigators of the study prepared a detailed demo-video showing insertion of a jugular central venous catheter with USG guidance. Principal investigator will vocalize the video in real-time. | Other | GControl, GModel |
| UltrasoundImagingParticipants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject. | Other | GControl, GModel |
| ModelTrainingParticipants will exercise the proper punction of juguler vein with USG guidance on the homemade jugular venous catheterization training model. Training model will include carotid artery, trachea and plaure in accordance with the real anatomy. | Other | GModel |
Primary outcome
Success Of The Catheterization
Time frame: 5 minutes
Successful visualization of the jugular vein in long axis, successful puncture and draining the fluid in the jugular vein, successful visualization of insertion of the guide wire. All required.
6 secondary outcomes
Successful Visualization
Time frame: 5 minutes
Time Of The Successful Visualization
Time frame: 5 minutes
Puncture Count
Time frame: 5 minutes
Number Of Changes Of Needle Angle During The Procedure
Time frame: 5 minutes
Puncture Time
Time frame: 5 minutes
Fail Of The Procedure
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lecture, Demo Video and UltrasoundImaging in people with Central Venous Catheters and Vascular Access Devices, run by Zeki Tuncel Tekgul at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Of The Catheterization (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.